Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

Barcelona Institute for Global Health

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Study type: Observational

Funder types: Other

Identifiers

NCT01388218

PROactive WP4

Details and patient eligibility

About

The purpose of the protocol is to develop final draft PRO instruments of physical activity in daily life to be used and evaluated in the further validation studies measuring physical activity in chronic obstructive pulmonary disease (COPD) patients.

Enrollment: 236 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria: post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)<70%) confirmed with spirometry in stable clinical conditions. For patients recruited during an exacerbation, the diagnosis of COPD should be confirmed in stable conditions.
• Current or ex-smokers with a smoking history equivalent to at least 10 pack years.
• Able to read and write and to use electronic devices and physical activity monitor.

Exclusion criteria

• Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator.
• Respiratory diseases other than COPD (e.g. asthma).
• Cognitive impairment, as judged by the investigator

Trial design

236 participants in 2 patient groups

Arm 1 - Daily+Clinical

Description:

Order of assessment: Daily PRO + Clinical visit PRO

Arm 2 - Clinical+Daily

Description:

Order of assessment: Clinical visit PRO + Daily PRO